Senior Quality Risk Management Lead – Pharma/Biotech (ICH Q9)

LSC, Life Science Consultants; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

LSC is seeking a Quality Risk Management Lead for a 12‑month contract at a state‑of‑the‑art biopharma campus in Limerick, Ireland. The role requires extensive GMP/pharma/biologics QRM experience and strong knowledge of ICH Q9, with emphasis on risk assessment practices and a move to digital systems.

You will lead cross‑functional risk activities, influence site quality governance, and manage stakeholder meetings in a high‑caliber manufacturing environment.

Qualifications

• Extensive QRM experience in GMP-regulated pharma/biologics.
• Strong knowledge of ICH Q9 and digital manufacturing concepts.
• Ability to operate at a strategic level influencing quality governance.

Responsibilities

• Design and implement a facility-wide QRM framework aligned with ICH Q9(R1).
• Lead senior risk management activities across functions from risk questions to resolution.
• Discuss methodologies in detail during interviews and ensure robust risk handling.
• Prioritize risks by urgency and business impact; manage stakeholder meetings.
• Navigate cross-functional risk assessments and adapt approaches as needed.
• Utilize risk assessment tools and prepare transition to an electronic system.
• Maintain thorough knowledge of FMEA as the core risk assessment method.

Skills

Quality Risk Mgmt

Stakeholder mgmt

Risk assessment

ICH Q9 knowledge

Digital manufacturing

Tools

FMEA

Job description

LSC is seeking a Quality Risk Management Lead for a 12‑month contract at a state‑of‑the‑art biopharma campus in Limerick, Ireland. The role requires extensive GMP/pharma/biologics QRM experience and strong knowledge of ICH Q9, with emphasis on risk assessment practices and a move to digital systems.

You will lead cross‑functional risk activities, influence site quality governance, and manage stakeholder meetings in a high‑caliber manufacturing environment.